Correction made to automated approval process for certain HCC exception candidates

Published on: Monday, December 4, 2023

Effective Oct. 25, 2023, a correction has been made to the programming criteria for auto-approving a MELD or PELD exception score for a specific group of liver transplant candidates who have hepatocellular carcinoma (HCC) with Class 5 lesions. Under the previous process, a small number of candidates were automatically approved for an exception score in error, when instead the National Liver Review Board (NLRB) should have considered each case individually and voted on an exception based on the candidate’s individual condition.

At the time of the correction, 30 current liver transplant candidates had erroneously received an automatic approval score. At a meeting held Oct. 24, 2023, the OPTN Executive Committee determined that those candidates may retain their assigned score until it is scheduled to expire according to the schedule in OPTN policy.

Background

OPTN policy allows HCC candidates who meet certain medical criteria to qualify for automatic approval of an assigned exception score, without individual consideration by the NLRB. Among the various auto-approval pathways, OPTN Policy 9.5.I.vi addresses candidates with Class 5 HCC lesions who meet a set of requirements as assessed by clinical imaging.

OPTN Policy Table 9.9 lists the various pathways for exception score approval. For candidates in class 5A, the policy’s intent is that candidates must meet all three conditions to be auto-approved under that pathway. However, it was recently determined that some candidates with at least one HCC tumor in the 5A classification were auto-approved despite not meeting all three criteria.

Under the Oct. 25 update, only candidates meeting all three criteria will be automatically approved. Any candidate in this classification not meeting all requirements will instead be considered individually by the NLRB.

Liver transplant candidates and their families may learn more about the exception score process in this frequently asked questions document, under the header, “How are exception scores decided?”

For additional information regarding this specific action, refer to the briefing document developed to inform the OPTN Executive Committee decision.